[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100486711":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":30,"studyPopulation":30,"armGroups":37,"interventions":47,"overallOfficials":72,"centralContacts":77,"locations":82,"responsibleParty":99,"collaborators":30,"id":103,"slug":104,"hasResults":105,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":30,"eligibilityCriteria":109,"healthyVolunteers":105,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":30,"studyType":116,"phases":117,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":126,"whyStopped":30,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Baptist Health South Florida","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Overall survival (OS)","OS is defined as time from transplant to death due to any cause","2 years",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Disease-free survival (DFS)","DFS is defined as the time from transplant to relapse, progression, death due to any cause, whichever occurs first.",{"measure":18,"description":19,"timeFrame":12},"Transplant-related mortality (TRM)","Incidence of TRM defined as mortality related to the transplant rather than the disease",{"measure":21,"description":22,"timeFrame":12},"Acute graft vs. host disease (GVHD)","Incidence of acute GvHD as graded using the International Bone Marrow Transplant Registry Severity Index, which includes assessment of skin, liver, and gut, grading each's severity from 0 to 4 (higher numbers reflecting the more severe disease). The overall assessment is based on the involvement and severity of each of the areas. A = Stage 1 skin involvement, no liver or gut involvement; B = Stage 2 skin involvement, Stage 1 to 2 gut or liver involvement; C = Stage 3 skin, liver or gut involvement; D = Stage 4 skin, liver, or gut involvement.",{"measure":24,"description":25,"timeFrame":12},"Chronic graft vs. host disease (GVHD)","Incidence of chronic GvHD as graded using the NIH scoring system, which includes assessment of skin, mouth, eyes, GI tract, liver, lungs, joint\u002Ffascia, and genital tract and grades the severity of affected organs from 0 to 3 (higher scores reflecting the more severe disease). The overall assessment is based on the number of organs\u002Fsites with clinically significant functional impairment (i.e., score 2-3). No GVHD = no organs\u002Fsites with significant functional impairment; Mild GVHD = involves two or fewer organs\u002Fsites with significant functional impairment; Moderate GVHD = involves three or more organs\u002Fsites with significant functional impairment -OR- involves one or zero organs\u002Fsites with NO significant functional impairment; Severe GVHD = Major disability caused by chronic GVHD.",{"measure":27,"description":28,"timeFrame":29},"Proportion of patients receiving optimal vs. suboptimal CD34+\u002FCD3+ PBSC doses","Proportion of patients receiving optimal CD34+ (\\>5 × 10\\^6\u002Fkg) and CD3+ (\\\u003C 5 ×10\\^4\u002Fkg) cell doses versus the proportion recurring suboptimal doses (\\\u003C3 × 10\\^6\u002Fkg) CD34+ cells; and the proportion of patients receiving CD3+ T-cell doses (\\>5 × 10\\^4\u002Fkg)","Day 0",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":30,"primaryPurpose":34,"observationalModel":30,"timePerspective":30,"maskingInfo":35},"NA","SINGLE_GROUP","TREATMENT",{"masking":36,"maskingDescription":30,"whoMasked":30},"NONE",[38],{"label":39,"type":40,"description":41,"interventionNames":42},"CD34+ Peripheral Blood Progenitor Cell (PBSC) Transplant with Busulfan\u002FMelphalan\u002FFludarabine Regimen","EXPERIMENTAL","1. Cytoreduction therapy:\n\n   1. 0.8 mg\u002Fkg q6h x 12 doses busulfan via IV injection (dose may be modified according to pharmacokinetics)\n   2. 70 mg\u002Fm²\u002Fday x 2 days melphalan via IV infusion over 30 minutes\n   3. 25 mg\u002Fm²\u002Fday x 5 days fludarabine (50 mg\u002Fm²\u002Fday in patients ≥65 years with a comorbidity score of ≥3) via IV infusion over 30 minutes\n2. CD34+ selected, T-cell depleted, allogeneic PBSC transplant using CliniMACS system to select CD34+ cells",[43,44,45,46],"Drug: Busulfan","Drug: Melphalan","Drug: Fludarabine","Device: CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC)",[48,55,61,67],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DRUG","Busulfan","0.8 mg\u002Fkg q6h × 12 doses via IV injection on Days -9, -8, and -7 prior to transplant",[39],[54],"Busulfex",{"type":49,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Melphalan","70 mg\u002Fm²\u002Fday × 2 days (50 mg\u002Fm²\u002Fday is patients ≥65 years with a comorbidity score of ≥3) via IV infusion over 30 minutes on Days -6 and -5 prior to transplant",[39],[60],"Alkeran",{"type":49,"name":62,"description":63,"armGroupLabels":64,"otherNames":65},"Fludarabine","25 mg\u002Fm²\u002Fdays × 5 days via IV infusion over 30 minutes on Days -6, -5, -4, -3, and -2 prior to transplant",[39],[66],"Fludara",{"type":68,"name":69,"description":70,"armGroupLabels":71,"otherNames":30},"DEVICE","CliniMACS CD34+ enriched, T-cell depleted peripheral blood stem cell (PBSC)","CliniMACS system will be used to derive CD34+ enriched, T-cell depleted (T-cells limited to 1.0 x 10\\^5 CD3+ cells\u002Fkg) PBSC for transplant, which will occur on Day 0. PBSC (5 x 10\\^6 CD34+ cells\u002Fkg) are suspended in a volume of approximately 20-50 mL and delivered via IV infusion over 15 minutes.",[39],[73],{"name":74,"affiliation":75,"role":76},"Guenther Koehne, M.D., Ph.D.","Baptist Health Herbert Wertheim Cancer Insitute","PRINCIPAL_INVESTIGATOR",[78],{"name":74,"role":79,"phone":80,"phoneExt":30,"email":81},"CONTACT","(786) 596-2000","GuentherK@baptisthealth.net",[83],{"facility":84,"status":30,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Baptist Health Herbert Wertheim Cancer Institute","Miami","Florida","33176","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-80.19366,25.77427,{"lat":94,"lon":93},[97],{"name":98,"role":79,"phone":80,"phoneExt":30,"email":81},"Guenther Koehne, M.D.",{"type":100,"investigatorFullName":101,"investigatorTitle":102,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Guenther Koehne","Deputy Director and Chief of Blood and Marrow Transplant, Hematologic Oncology and Benign Hematology","100486711","phase-2-cd34-enriched-transplants-to-treat-myelodysplastic-syndrome-100486711",false,"NCT05617625","CD34+ Enriched Transplants to Treat Myelodysplastic Syndrome","A Phase II Trial of CD34+ Enriched Transplants From HLA-Compatible Related or Unrelated Donors for Treatment of Patients With Myelodysplastic Syndrome","Inclusion Criteria:\n\n* MDS patients who qualify for transplant, for which CD34+ selected, T-cell-depleted allogeneic hematopoietic stem cell transplantation is indicated\n\n  1. Patients with high-risk features with a score equal to or higher than 4.5 using the IPSS-R.\n  2. Patients with therapy-related MDS and patients with transfusion-dependent MDS are high-risk patient cohorts that are eligible independent of Revised International Prognostic Scoring System (IPSS-R) scoring.\n* Patient's age is from ≥18 to ≤72 years old.\n* Patients must have an appropriately matched donor (MRD 8\u002F8, MUD 8\u002F8, or MMUD 7\u002F8 \\[mismatch at HLA-A, B or DR-B1 locus\\])\n* Patients may be of either gender or any ethnic background.\n* Patients must have a Karnofsky (adult) Performance Status of at least 70%\n* Patients must have adequate organ function measured by:\n\n  1. Cardiac: asymptomatic; left ventricular ejection fraction (LVEF) at rest must be ≥ 50%.\n  2. Hepatic: \\\u003C 3 × upper limit of normal (ULN) aspartate aminotransferase (AST) and \\\u003C 1.5 × ULN total serum bilirubin unless there is congenital benign hyperbilirubinemia or if the hyperbilirubinemia is directly caused by the disease in which the patient is receiving a transplant. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible for Pl approval e.g., patients with paroxysmal nocturnal hemoglobinuria (PNH), Gilbert's disease, or other hemolytic disorders.\n  3. Renal: serum creatinine: within the normal range 0.7-1.3 mg\u002FdL or if serum creatinine is outside the normal range, then creatinine clearance (CrCl) \\> 45 mL\u002Fmin (measured or calculated\u002Festimated via Cockcroft-Gault formula).\n  4. Pulmonary: asymptomatic \\[but sustained diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50% of predicted (corrected for hemoglobin)\\].\n* Each patient must be willing to participate as a research subject and must sign an informed consent form.\n\nExclusion Criteria:\n\n* Individuals who are pregnant or breastfeeding\n* Uncontrolled bacterial, viral, or fungal infections; or known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.\n\n  1. Patients cured of Hepatitis C for ≥3 years prior to enrollment are permitted\n  2. Patients with detectable hepatitis B surface antigen (HBsAg) will be excluded. Patients with detectable hepatitis B surface antigen (HBsAg) are excluded. Patients with viral hepatitis B core antibody (HBcAb) positivity, but absence of HBsAg, are eligible if hepatitis B virus (HBV) DNA is undetectable and if they are willing to be on hepatitis B antiviral prophylaxis and undergo monitoring for HBV reactivation (every 12 weeks while on immune suppression) per institutional protocols. Patients will be referred promptly to hepatology specialists with the first detectable viral load.\n* Symptomatic cardiac disease (angina, congestive heart failure) and\u002For LVEF \\\u003C50%\n* History of cardiovascular disease, including but not limited to myocardial infarction, unstable angina, stroke, or transient ischemic attack within the 6 months prior to the initiation of study or congestive heart failure (New York Heart Association \\[NYHA\\] class III-IV)\n* Patients who subsequently receive a non-T-cell-depleted transplant\n* Stem cell count \\\u003C3.0 × 106\u002Fkg following CD34+ selection\n* Known sensitivity to components of CliniMACS® Prodigy CD34 System 8. Have a history of other active malignancy(ies) unless the patient has been disease-free for at least 2 years and is deemed by the treating Investigator to be at low risk for recurrence of that malignancy; or the only prior cancer is curatively treated cervical cancer in situ, or basal cell or squamous cell carcinoma of the skin.","ALL","18 Years","72 Years",{"count":114,"type":115},62,"ESTIMATED","INTERVENTIONAL",[32],"This study will evaluate whether processing blood stem cell transplants using an investigational device (the CliniMACS system) results in fewer complications for patients who undergo transplant to treat myelodysplastic syndrome (MDS).\n\nThe CliniMACS system will be used to remove immune T-cells from the transplant donor's blood. Immune T-cells contribute to graft versus host disease (GVHD) - a serious complication that can happen after transplant. GVHD occurs when a patient's immune system attacks the donor's cells. The study aims to reduce the number of the donor immune T-cells thereby preventing or reducing the severity of GVHD.",[120,121,122],"Myelodysplastic Syndromes","Graft Vs Host Disease","Graft-versus-host-disease",[124,125],"stem cell transplant","allogeneic transplant","NOT_YET_RECRUITING","2026-10-08",{"date":129,"type":130},"2026-10-13","ACTUAL",{"date":132,"type":115},"2027-01",{"date":134,"type":115},"2034-01",{"name":101,"class":6},1]